Osseointegration in amputee patients

Osseointegration is a revolutionary technology for amputees. The term amputation refers to the loss of all or part of a limb. It can occur as a result of trauma or scheduled surgery for other medical reasons. Most procedures are performed to treat complications resulting from peripheral vascular disease (PVD) or diabetes. The next most common cause of amputation is trauma from traffic accidents and war wounds. Less commonly, patients undergo amputation to treat a limb tumor, infection or congenital disease.

Funnel-set lower limb prostheses are now the standard method of supply for patients with limb loss. Although significant advances have been made in prosthetic technology, fitting the socket remains a challenge and is often one of the most difficult aspects of the physiotherapy process. Achieving the optimal fit of a prosthesis after an arm or leg amputation without pressure points, adequate flexibility versus stiffness and durability remain elusive for a large percentage of patients. Despite continued research into funnel and insole technologies, the modern socket remains a major reason why many amputees cannot improve mobility, independence and quality of life.

Osseointegration is a revolutionary technology for upper or lower limb amputees, offering a viable solution for patients who have problems with traditional prostheses attached through a funnel. Unlike traditional methods, osseointegration upper limb prostheses attach directly to the bone, so it restores the mechanical axis of the limb close to natural physiological conditions. This allows freedom of movement, better control of the limb and reduced pain. Once fully integrated, the system allows simple, fast and safe connection of the stump to a modern lower limb prosthesis.

Before surgery indications

Currently, osseointegration technology is possible for treating above- and below-knee amputations, among other things. The doctor may suggest surgery if the patient has problems using a conventional prosthesis. The inability to use a funnel-mounted prosthesis can be caused by, among other things:

1. Pain after lower limb amputation or pain in the lumbar spine,
2. Recurrent skin infections and ulcers at the site of contact,
3. A stump that is too short, preventing the effective use of dentures,
4. Volume fluctuations in the trunk,
5. Extensive scarring or skin grafting,
6. excessive sweating,
7. limited mobility.

Surgical criteria may include:

• The level of patient cooperation according to the medical protocol,
• Proper patient understanding of the benefits and risks of the procedure,
• BMI<40 (niewielka liczba pacjentów z chorobliwą otyłością przeszła skuteczne leczenie, jako że ostatecznie nie mogli nosić leja),
• Controlling blood glucose levels, especially in patients with diabetes,
• No smoking for at least 3 months before the operation.

Contraindications:

• Active infection of the limb stump requiring treatment after amputation,
• Bone irradiation within the limb,
• pregnancy,
• mental instability.

Before treatment decision

The decision to have surgery is entirely up to the patient. It should be made consciously, knowing and understanding its benefits and risks. The doctor cannot guarantee that osseointegration will meet all expectations. The support of loved ones, a comprehensive assessment of the medical team and the results of the indicated tests can be helpful in making the decision.

Support for people with Osseointegration

Talking to someone who has undergone surgery can play an important role in preparation, recovery and physiotherapy. Answering questions such as how long it takes to heal after an amputation, what to treat wounds with from a prosthesis, and what types of lower limb prostheses are available can help not only to understand the treatment and rehabilitation process, but also to mentally prepare for the changes that will follow surgery. At Paley European Institute, our psychologist Anna Nykiel is at your service.

Support of the medical team

From the decision to operate through care during pain management, physiotherapy and prosthetic adjustments to the limb, surgery requires a multidisciplinary approach. The medical team is there to assess the condition and determine a comprehensive treatment plan. Open communication is an essential part of success. Each patient is under the care of a Medical Care Coordinator who will accompany them through all stages of treatment.

Indications for treatment

In order to obtain the necessary information to assist in decision-making and required care, the patient must undergo several objective, subjective and radiological examinations. These will take place both before surgery and regularly throughout the treatment process.

Expectations

Not every patient will achieve the same results. Only a realistic approach to the entire treatment process and the individual results that can be achieved qualifies a patient for the procedure. A prosthesis after amputation is a tool to improve the quality of life, but its effectiveness depends on many factors, including the patient's level of commitment to the rehabilitation process, his or her overall health and individual predispositions.

Consent form

If you opt for lower limb prostheses, your doctor will ask you to sign a consent form. It should be read carefully. If you have any questions, the medical team remains available.

Before treatment

The doctor needs to know the patient's entire medical history in order to plan the best treatment. He or she should be informed of any health problems, especially allergies, prolonged bleeding, blood clotting problems or mental illness. If the patient has diabetes, discuss this with the doctor before the operation.

Radiological assessments

To help develop a treatment plan, your doctor will require certain X-rays, CT scans and DEXA (bone density) scans. You should bring the images and test results with you to your appointment.

Custom implants

Sometimes a surgeon may request a custom implant to ensure a precise fit to the stump. These are specifically designed based on the patient's anatomy so that they are an exact fit to the bone. Custom implants require additional planning and manufacturing time. It is up to the doctor to decide whether they need to be prepared.

Travel

Arrival for the osseointegration procedure should take place several days before the scheduled operation. It is advisable for the patient to be accompanied by a support person. Arrival in advance will allow the patient to familiarize himself with his new surroundings.

Stump skin diseases

Before the procedure, it is advisable to optimize the condition of the skin. Excessive use of the funnel should be avoided for two weeks before surgery, as this can cause lacerations and abrasions. If the area near the incision site becomes infected, the entire team should be informed, as this may delay surgery.

Pre-admission inspection

The patient will be asked to attend an additional appointment before the date of the operation to make sure his or her condition is suitable for it.

Preoperative conditioning

Some patients may be advised to undertake a preoperative preparation program. It may be necessary to optimize upper body and trunk strength. For lower extremity amputations, it is important to learn to use crutches. Any deformity should also be identified and properly addressed. DEXA scans are essential to assess the degree of osteoporosis and resorption of diseased bone. Patients may have varying levels of osteoporosis depending on age, gender, time since amputation and activity. Vitamin D3 and regular exercise are also recommended. The degree of osteoporosis will also determine the rate of postoperative physiotherapy.

Surgical procedure

Osseointegration is usually performed during a single operative session. Historically, the two-stage procedure was performed with an interval of 4 to 6 weeks. In 2014, a single-stage surgical approach was introduced to speed up physiotherapy for patients and reduce the risks associated with multiple surgeries. In rare cases, multiple stages may still be required.

Anesthesia

The operation is usually performed under regional, intrathecal anesthesia with a subarachnoid (PP) or epidural (ZO) block to stop pain and sensation from the waist down. It is supplemented with sedation. Modern anesthesia is safe and effective, but comes with risks. The anesthesiologist will carefully explain the entire anesthesia process.

Operation

An incision will be made at the far end of the stump. The wound will then be opened in layers to expose the end of the remaining bone. The end of the bone is prepared with special tools, removing any unwanted growths. In the next step, the doctor will examine and remove any neuroma. The muscles will be reorganized and grouped peripherally using special sutures by attaching them directly to the bone. This will allow for future control of the prosthetic lower or upper limb with the muscles.

Implant insertion

The bone canal is then prepared by sequential reaming with special reamers that transform the bone canal from oval to cylindrical. Then gauges are used and their shape is adjusted. All extracted bone is carefully harvested for bone grafting. Once the desired size of the canal is achieved, the bone graft will be inserted into the defect and the implant will be carefully pressed into the canal.

Surgical closure

A soft tissue flap is prepared by removing excess subcutaneous tissue. This flap is then used to cover the muscle, the implant, and is fixed in place with sutures. A circular hole is created in the skin at the end of the implant. A percutaneous prosthesis is carefully attached to the implant through this hole. A wound dressing is then placed over the wound.

Physiotherapy

After surgery, the patient will be provided with a set of pain medications. A balanced pain relief protocol allows you to control your muscles and maintain good cognitive status. This allows physiotherapy to begin with adequate pain relief. The hospital stay usually lasts 3 to 5 days, after which the patient is discharged home.

Wound care

After removing the surgical dressing, the wound will be cleaned and allowed to air out. It is recommended to use a simple 4×4 gauze as a non-occlusive dressing. The goal is to allow leakage to be removed instead of accumulating inside the wound. Instead of covering the wound at all times, the patient should try to keep the wound dry and exposed to the sun. Skin sutures are usually removed partially after 3 weeks and completely after 4 weeks.

Pain in the limbs

Limb pain can be caused by many factors, and treatment must target the root cause. Muscle pain is expected to worsen in the initial stages after surgery. This is because they are starting to be used for the first time since the initial amputation. This pain will vary in severity and duration depending on the level of activity, the degree of muscle atrophy and the time required to rebuild these muscles. The pain caused by the bone outgrowths will be eliminated by their surgical removal as part of the operation. Skin irritation pain caused by the funnel is expected to be completely eliminated. However, it may be replaced by another type of pain at the site where the implant protrudes. It can be treated with a topical anesthetic cream.

Phantom limb pain is usually treated by local excision during surgery or later with injections or painkillers. Phantom limb pain is the most complicated to treat. Although it is likely that phantom limb pain will decrease after osseointegration, the exact mechanisms and underlying phenomena are unknown. Pain management specialists use a multifaceted approach, from medications to nerve stimulators. Physiotherapy generally involves 3 stages. Prior to osseointegration surgery, the patient is given a detailed treatment plan, according to which the patient will be guided throughout the process. after surgery, excessive physical activity should be avoided.

PHASE I consists of static loading by standing on a bathroom scale using a weight device attached to the implant. Exercise is done for 20 minutes twice a day. This phase can start as early as the day after surgery and involves 50% of the body weight or max. 50 kg. Weight-bearing is started with 5 kg loads, and the rate of growth is determined by bone status measured preoperatively by DEXA and intraoperative assessments.

PHASE II applies only to knee amputees and involves adjusting the leg for gait training. The patient can begin to take the first steps, assisted by parallel handrails, and when it is safe to do so, one can move to using two crutches.

PHASE III involves fitting and alignment of the final upper and lower limb prosthesis. Once fitted, the patient can walk with two crutches for 6 weeks, and then with one crutch for another 6 weeks. In the following weeks, he can already walk without assistance. This is necessary to minimize the risk of falls and prevent premature overloading of the implant.

Recovery takes time

Excessive physical activity should be avoided for the first 12 months after surgery.

Ongoing care

About 3-4 months after surgery, most patients complete physiotherapy and can walk without any assistive devices. However, it is important to visit the prosthetist and physiotherapist regularly, as gait and balance will improve over time. The prosthetist will provide instructions on how the safety mechanism works and how to properly replace it if it breaks during a fall or other accident.

Excessive discharge from the skin integration site after surgery is very normal and usually subsides 3-6 months after surgery. It is more intense in women and overweight patients. It is usually yellow or transparent in color. To improve hygiene, a split gauze dressing can be placed around the transdermal adapter and gently taped to the metal parts. Warm baths in salt water can also effectively reduce the amount of discharge.

Daily hygiene

When you leave the hospital after the osseointegration procedure, you should shower daily. The stump should be washed gently with soap and water. Ideally, you should rinse daily with a handheld showerhead. It is also recommended to use a natural soap that does not contain perfumes or moisturizers. When bathing, a clean, soft baby toothbrush can be used to remove dried blood and secretions from metal parts. Swimming in a saltwater pool or in the ocean is recommended. Rinse the wound after swimming, especially in public places. To promote healing, keep the wound dry and uncovered.

A lower or upper limb prosthesis with osseointegration is designed to become a permanent extension of the skeletal structure. The Paley European Institute team will explain how each component works, including any required regular maintenance and services. As activity levels increase, the components may gradually loosen and will need to be tightened regularly every three months.

Infections

Despite a significant reduction in infection rates following single-stage surgery and improvements in surgical techniques, infection remains a major risk associated with osseointegration. Pain, redness, fever or unusual leakage should be reported immediately to the medical team. The condition should be described in as much detail as possible and photos sent to help make a diagnosis. Do not start antibiotic treatment until the type of infection is determined.

Support

Osseointegration is a lifelong commitment. The international osseointegration network is continually training new doctors from centers around the world to provide local support to all patients. Any questions or concerns can also be directed to selected members of the osseointegration network.

Possible complications

As with all surgical procedures, osseointegration surgery carries risks, despite the highest standards of practice. It is important to have enough information about possible complications to fully weigh the benefits, risks and limitations of treatment. The complications outlined below are among the least common.

Complications that may occur:

• Severe multi-organ failure, ending in death inclusive,
• Severe systemic infection,
• loss of the remaining limb,
• Blood clots in the deep veins, which can be life-threatening,
• Fracture of the implant or its components,
• Bone fracture around the implant,
• An adverse reaction to anesthetics, antibiotics, sutures or dressing materials,
• temporary or permanent damage to nerves or blood vessels near the surgical field,
• chronic infections that may require oral, intravenous antibiotics or even removal of the implant and return to the alveolus.

The aforementioned complications are the least common. More common are minor infections, which can occur at any time, even several months after surgery. However, they most often occur 2-3 weeks after surgery, and their frequency decreases with time. In most cases, only oral antibiotics are used to treat infections. In rare cases, intravenous antibiotics or surgical debridement of infected tissue may be needed.

In extreme cases, a second surgery may be needed to remove the implant, followed by a third surgery to reinsert it. The implant may loosen over time due to infection, trauma, overload or in some cases for no known reason.

Dental care vs. surgical care

If you are having dental or other surgeries, even minor ones, you should inform your dentist or surgeon about the osseointegrated implant. Prophylactic antibiotics may need to be administered before and after surgery to reduce the risk of infection around the denture.

Important!

Contact your osseointegration team immediately if you experience any of the following symptoms:

• Temperature higher than 38.5C (fever) or chills,
• Severe pain or tenderness,
• Profuse bleeding from the incision,
• The spread of redness around the wound,
• Nausea or vomiting,
• reduced mobility of the limbs,
• Trauma, fall, and inability to load the implant,
• Any other symptoms related to the operation.

Treatment costs

The treatment plan will also include a cost estimate. Please note that it is prepared individually by the pediatric orthopedics team, as each case is different.